eTraining – Vigilance Reporting – EU Regulation

Within this e-Training, you will get 4 modules:

Introduction to Vigilance Reporting
EU Regulation Requirements
Reporting procedure (forms to use)
Trend Reporting

At the end, you will have an exam to pass. You’ll receive your certificate after its completion.

Don’t hesitate to ask your questions by sending us an email.

About this e-learning

This e-learning is about Vigilance Reporting for EU MDR and IVDR. The training will focus around Article 87 (EU MDR) and article 82 (EU IVDR). It will provide all the expert advice to execute a vigilance reporting for your company.

Key learning objectives

By the end of this course, you will be able to:

Recognize what is an incident (event) and how to handle it within your company.
Identify the structure of your Quality Management System for handling vigilance reporting.
The EU MDR and IVDR parameters to take into account.
The documents that you need to provide to the authorities for executing the vigilance reporting.
The definition of Trend Reporting. And how to establish a process to identify it within your company.

Who should attend?

This Vigilance Reporting training is helpful for all medical device professionals and management and executive personnel looking to expand their knowledge on the EU MDR and IVDR

Certificate

By completing this course, you will receive a certificate of participation.